What Is It?
Hydroxystearic Acid is a A natural organic compound that consists of a carboxyl group (oxygen, carbon and hydrogen) attached to a chain of carbon atoms with their associated hydrogen atoms. The chain of carbon atoms may be connected with single bonds, making a ‘saturated’ fat; or it may contain some double bonds, making an ‘unsaturated’ fat. The number of carbon and hydrogen atoms in the chain is what determines the qualities of that particular fatty acid. Animal and vegetable fats are made up of various combinations of fatty acids (in sets of three) connected to a glycerol molecule, making them triglycerides.. In cosmetics and personal care products, Hydroxystearic Acid is used in skin care preparations.
Why Is It Used?
Hydroxystearic Acid cleans skin and hair by helping water to mix with oil and dirt so that they can be rinsed away.
Hydroxystearic Acid is structurally similar to stearic acid and both are obtained from naturally-occurring fats and oils. One method of production of Hydroxystearic Acid involves the hydrogenation of castor oil.
The Food and Drug Administration (FDA) includes Hydroxystearic Acid on its list of indirect food additives for use as a component of paper and paperboard, and as a lubricant having incidental contact with food.
The safety of Hydroxystearic Acid has been assessed by the The Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel reviewed the available scientific data and concluded that Hydroxystearic Acid was safe as a cosmetic ingredient in the present practices of use.
CIR Safety Review: The CIR Expert Panel reviewed reproduction and developmental toxicity and genotoxicity data that found no significant effects at exposures likely to exceed that seen from expected cosmetic use concentrations. The sarcomas produced by subcutaneous injection of Hydroxystearic Acid were considered to be a physical phenomenon unrelated to the specific material injected and not relevant to the use of this ingredient in cosmetics. Under semioccluded and occluded patch testing conditions, the CIR Expert Panel recognized irritation was found with antiperspirant prototype formulations. It is the experience of the CIR Expert Panel that such formulations under those exaggerated conditions do produce irritation, but are not generally irritating in actual use.
FDA: Link to Code of Federal Regulations for Hydroxystearic Acid
Hydroxystearic Acid may be used in cosmetics and personal care products marketed in Europe according to the Under the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions.. Ingredients of animal origin must comply with European Union animal by-products regulations.
Link to the EU Cosmetic Regulation:
More Scientific Information
Hydroxystearic Acid, also known as 12-Hydroxyoctadecanoic Acid, is a used as a An ingredient that helps two substances that normally do not mix to become dissolved or dispersed in one another. Also called a surface active agent. – cleansing agent in cosmetic and personal care products. Cleansing agents, are used for skin and hair-cleaning purposes and as emulsifiers in cosmetics. In this function, surfactants wet body surfaces, emulsify or solubilize oils, and suspend soil.
It is characteristic (and expected by some consumers) that such agents should contribute foaming and lathering properties to cleansing products and bubble baths. The listing includes not only soaps but also fatty acids that yield soaps upon reaction with an alkali.
Find out more about the regulation of Food Additives by the Food and Drug Administration
Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm
Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…
Substances Generally Recognized As Safe (“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/